ARTICLE | Regulation

How omics will drive the next generation of surrogate endpoints

Next-gen tools offer more complete views of disease, drug response, but constraining their outputs is key

August 31, 2021 1:08 PM UTC

As omics tools find their footing in the clinic, they have the potential to reveal new, more predictive surrogate endpoints, and bolster confidence in existing ones. These emerging technologies could catalyze accelerated approvals in a wider range of disease areas, but reduction to practice will require overcoming data science challenges shared by all omics methods, and technical hurdles specific to individual approaches.

The transformative potential of expedited approval pathways has been overwhelmingly limited to cancer and infectious diseases, where surrogate endpoints that predict clinical benefit have been most obvious. ...